Association of Heart Failure Aggravation and Device-based Sensor Parameters
Running, not enrolling
Conditions studied: Heart Failure, Cardiomyopathy
In brief
This is a prospective, multicenter, observational patient registry designed to evaluate the association between changes in device-based sensor parameters and heart failure (HF) aggravation in patients implanted with Boston Scientific implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) equipped with HeartLogic™, Sleep Incline, and Apnea Scan functions. The study will prospectively collect remote monitoring and clinical follow-up data to determine whether changes in individual or combined device-based sensor parameters are associated with worsening HF events and to evaluate the clinical utility of remote monitoring for HF management.
Key facts
- Study ID
- NCT07753135
- Run by
- Samsung Medical Center
- People needed
- 500
- Starts
- 2023-02-01
- Expected to finish
- 2027-10-31
- Last updated by the study team
- 2026-08-07
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults aged 19 years or older who provide written informed consent (or consent from a legally authorized representative when applicable)
- Diagnosed with heart failure or cardiomyopathy Implanted with a commercially approved Boston Scientific implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) equipped with HeartLogic™, Sleep Incline, and Apnea Scan functions
- Enrolled in the LATITUDE™ (NXT 5.0 or later) remote monitoring system and willing to participate in scheduled remote monitoring and follow-up
You may not qualify if…
- Planned heart transplantation or implantation of a ventricular assist device (VAD), or history of VAD implantation within the previous 12 months
- Life expectancy of less than 1 year
- Inability or unwillingness to comply with the study protocol or follow-up requirements
Where it is running
- Samsung Medical Center — Seoul, Seoul, South Korea
Full record on ClinicalTrials.gov
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